Myocardial InfarctionPhase 2MYSTARNCT00384982
Myocardial Stem Cell Administration After Acute Myocardial Infarction (MYSTAR) Study
A Phase 2 study testing Bone marrow-derived stem cells implantation in people with Myocardial Infarction, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The MYocardial STem cell Administration after acute myocardial infaRction (MYSTAR) study is a multicenter, prospective, randomized, single-blind clinical trial designed to compare the early and late intracoronary or combined (percutaneous intramyocardial and intracoronary) administration of bone marrow-derived stem… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Bone marrow-derived stem cells implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2005to Aug 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with a definitive AMI not earlier than 21 days and not later than 42 days before randomization (day 0 is the day of infarction)
- Patients with open IRA without significant stenosis and TIMI flow 3, after successful percutaneous coronary intervention (PCI) of the IRA
- Patients with two- or three-vessel disease might be included after adequate PCI if no significant coronary lesion can be seen in the non-infarct-related major vessels at the time of BM-SCs therapy
- A persistent local new wall motion abnormality related to the recent infarct location.
- Preserved myocardial viability, at least in the part of the recent infarction should be demonstrated by a preserved wall thickness and/or hypokinesia determined by transthoracic echocardiography or contrast ventriculography, and preserved tracer uptake determined by early and late resting Thallium myocardial scintigraphy or FDG-PET.
- Global LVEF between 30 and 45%.
- Written informed consent.
Who cannot join
- Previous heart surgery
- Small posterior or inferior AMI
- Previous MI at the same location
- Regional wall motion abnormality outside the area involved in the index AMI
- Ventricular thrombus
- Severe valvular heart disease
Show all 15Show fewer
- Severe renal, lung and liver disease
- Disease of the hematopoetic system
- Hemoglobin level below 9 mg%
- The patient cannot follow the study protocol
- NYHA functional class IV at baseline
- Postinfarct angina
- Significant coronary stenosis in the IRA requiring repeated PCI at the time of the planned BM-SCs therapy
- Significant coronary lesion in one or more major coronary vessels, requiring revascularization
- Age lower than 18 years
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Cardiology, Medical University of Vienna
Vienna, 1090
About this study
Official title: Myocardial Stem Cell Administration After Acute Myocardial Infarction (MYSTAR) Study: A Multicenter, Randomized Trial Comparing Early and Late Intracoronary or Combined (Intramyocardial and Intracoronary) Administration of Stem Cells
The MYocardial STem cell Administration after acute myocardial infaRction (MYSTAR) study is a multicenter, prospective, randomized, single-blind clinical trial designed to compare the early and late intracoronary or combined (percutaneous intramyocardial and intracoronary) administration of bone marrow-derived stem cells to patients after acute myocardial infarction with reopened infarct-related artery.
Read the detailed description
Previous data suggest that bone marrow-derived stem cells (BM-SCs) decrease the infarct size and beneficially affect the postinfarction remodeling.
The MYocardial STem cell Administration after acute myocardial infaRction (MYSTAR) study is a multicenter, prospective, randomized, single-blind clinical trial designed to compare the early and late intracoronary or combined (percutaneous intramyocardial and intracoronary) administration of BM-SCs to patients after acute myocardial infarction (AMI) with reopened infarct-related artery.
The primary endpoints are the changes in resting myocardial perfusion defect size and left ventricular ejection fraction (gated SPECT scintigraphy) 3 months after BM-SCs therapy.
The secondary endpoints relate to evaluation of 1) the safety and feasibility of the application modes, 2) the changes in left ventricular wall motion score index (transthoracic echocardiography), 3) myocardial voltage and segmental wall motion (NOGA mapping), 4) left ventricular end-diastolic and end-systolic volumes (contrast ventriculography), and 5) the clinical symptoms (CCS and NYHA) at follow-up.
Patients are randomly assigned into one of four groups, Group A: early treatment (21-42 days after AMI) with intracoronary injection; Group B: early treatment (21-42 days after AMI) with combined (intramyocardial and intracoronary) application; Group C: late treatment (3 months after AMI) with intracoronary delivery; and Group D: late treatment (3 months after AMI) with combined (intramyocardial and intracoronary) administration of BM-SCs. Besides the BM-SCs therapy, the standardized treatment of AMI is applied in all patients.
The MYSTAR trial is the first randomized trial to investigate the effects of the combined (intramyocardial and intracoronary) and the intracoronary mode of delivery of BM-SCs therapy in the early and late periods after AMI.
- Conditions
- Myocardial Infarction
- Being tested
- Bone marrow-derived stem cells implantation
- Keywords
- Bone marrow-derived stem cells, Acute myocardial infarction
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone marrow-derived stem cells implantationProcedure or surgery
Also called early intracoronary delivery of BM-MNCs, late intracoronary delivery of BM-MNCs, early combined (intramyoc+intracor) delivery of BM-MNCs, late combined (intramyoc+intracor) delivery of BM-MNCs
percutaneous BM-derived cell therapy
| Study group | Role | What they receive |
|---|---|---|
| A, B, C, D | Experimental | Early or late; percutaneous intracoronary or combined (intramyocardial and intracoronary) administration of BM-MNCs Receives: Procedure: Bone marrow-derived stem cells implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in resting myocardial perfusion defect size by gated SPECT scintigraphy 3-6 months after the percutaneous intracoronary or combined bone marrow-derived stem cells therapy.
Measured: 3-6 month
Changes in global left ventricular ejection fraction by gated SPECT scintigraphy 3-6 months after the percutaneous intracoronary or combined bone marrow-derived stem cells therapy.
Measured: 3-6 month
Secondary outcomes (6)
The feasibility of the bone marrow-derived stem cells delivery modes, determined by the rates of acute and subacute complications
Measured: in-hospital
Change in the left ventricular wall motion score index, measured by transthoracic echocardiography
Measured: 3-6 month
Change in the myocardial voltage as a parameter of myocardial viability obtained by NOGA endocardial mapping, with segmental wall motion expressed by local linear shortening on NOGA mapping
Measured: 3-6 month
Change in left ventricular end-diastolic and end-systolic volumes by contrast ventriculography
Measured: 3-6 month
Assessment of the clinical symptoms (CCS and NYHA) of the patients
Measured: 3, 6 and 12 month
The safety of the bone marrow-derived stem cells delivery modes, expressed as the rates of long-term major adverse cardiac events (MACE: death, target vessel revascularization and non-fatal AMI)
Measured: 3, 6 and 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2006 (estimated)
- Study startJan 2005
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Irene Lang, MD, Study director, Department of Cardiology, Medical University of ViennaDietmar Glogar, MD, Study chair, Department of Cardiology, Medical University of ViennaMariann Gyongyosi, MD, Principal investigator, Department of Cardiology, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00384982
- Sponsor's protocol ID
- Medical University of Vienna
- Acronym
- MYSTAR
- Status last verified
- Aug 2008
- First submitted
- 5 Oct 2006
- Last updated
- 22 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Stem Cell Administration After Acute Myocardial Infarction (MYSTAR) Study: A Multicenter, Randomized Trial Comparing Early and Late Intracoronary or Combined (Intramyocardial and Intracoronary) Administration of Stem Cells
- ClinicalTrials.gov ID
- NCT00384982
- Acronym / sponsor ID
- MYSTAR / Medical University of Vienna
- Conditions
- Myocardial Infarction
- Keywords
- Bone marrow-derived stem cells, Acute myocardial infarction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 6 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The MYocardial STem cell Administration after acute myocardial infaRction (MYSTAR) study is a multicenter, prospective, randomized, single-blind clinical trial designed to compare the early and late intracoronary or combined (percutaneous intramyocardial and intracoronary) administration of bone marrow-derived stem cells to patients after acute myocardial infarction with reopened infarct-related artery.
Detailed description
Previous data suggest that bone marrow-derived stem cells (BM-SCs) decrease the infarct size and beneficially affect the postinfarction remodeling.
The MYocardial STem cell Administration after acute myocardial infaRction (MYSTAR) study is a multicenter, prospective, randomized, single-blind clinical trial designed to compare the early and late intracoronary or combined (percutaneous intramyocardial and intracoronary) administration of BM-SCs to patients after acute myocardial infarction (AMI) with reopened infarct-related artery.
The primary endpoints are the changes in resting myocardial perfusion defect size and left ventricular ejection fraction (gated SPECT scintigraphy) 3 months after BM-SCs therapy.
The secondary endpoints relate to evaluation of 1) the safety and feasibility of the application modes, 2) the changes in left ventricular wall motion score index (transthoracic echocardiography), 3) myocardial voltage and segmental wall motion (NOGA mapping), 4) left ventricular end-diastolic and end-systolic volumes (contrast ventriculography), and 5) the clinical symptoms (CCS and NYHA) at follow-up.
Patients are randomly assigned into one of four groups, Group A: early treatment (21-42 days after AMI) with intracoronary injection; Group B: early treatment (21-42 days after AMI) with combined (intramyocardial and intracoronary) application; Group C: late treatment (3 months after AMI) with intracoronary delivery; and Group D: late treatment (3 months after AMI) with combined (intramyocardial and intracoronary) administration of BM-SCs. Besides the BM-SCs therapy, the standardized treatment of AMI is applied in all patients.
The MYSTAR trial is the first randomized trial to investigate the effects of the combined (intramyocardial and intracoronary) and the intracoronary mode of delivery of BM-SCs therapy in the early and late periods after AMI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A, B, C, D | Experimental | Procedure: Bone marrow-derived stem cells implantationEarly or late; percutaneous intracoronary or combined (intramyocardial and intracoronary) administration of BM-MNCs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient with a definitive AMI not earlier than 21 days and not later than 42 days before randomization (day 0 is the day of infarction)
- Patients with open IRA without significant stenosis and TIMI flow 3, after successful percutaneous coronary intervention (PCI) of the IRA
- Patients with two- or three-vessel disease might be included after adequate PCI if no significant coronary lesion can be seen in the non-infarct-related major vessels at the time of BM-SCs therapy
- A persistent local new wall motion abnormality related to the recent infarct location.
- Preserved myocardial viability, at least in the part of the recent infarction should be demonstrated by a preserved wall thickness and/or hypokinesia determined by transthoracic echocardiography or contrast ventriculography, and preserved tracer uptake determined by early and late resting Thallium myocardial scintigraphy or FDG-PET.
Key exclusion criteria (15 listed)
- Previous heart surgery
- Small posterior or inferior AMI
- Previous MI at the same location
- Regional wall motion abnormality outside the area involved in the index AMI
- Ventricular thrombus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone marrow-derived stem cells implantationAlso: early intracoronary delivery of BM-MNCs, late intracoronary delivery of BM-MNCs, early combined (intramyoc+intracor) delivery of BM-MNCs, late combined (intramyoc+intracor) delivery of BM-MNCspercutaneous BM-derived cell therapy | Procedure or surgery | A, B, C, D |
Primary outcome
Changes in resting myocardial perfusion defect size by gated SPECT scintigraphy 3-6 months after the percutaneous intracoronary or combined bone marrow-derived stem cells therapy.
Time frame: 3-6 month
Changes in global left ventricular ejection fraction by gated SPECT scintigraphy 3-6 months after the percutaneous intracoronary or combined bone marrow-derived stem cells therapy.
Time frame: 3-6 month
6 secondary outcomes
The feasibility of the bone marrow-derived stem cells delivery modes, determined by the rates of acute and subacute complications
Time frame: in-hospital
Change in the left ventricular wall motion score index, measured by transthoracic echocardiography
Time frame: 3-6 month
Change in the myocardial voltage as a parameter of myocardial viability obtained by NOGA endocardial mapping, with segmental wall motion expressed by local linear shortening on NOGA mapping
Time frame: 3-6 month
Change in left ventricular end-diastolic and end-systolic volumes by contrast ventriculography
Time frame: 3-6 month
Assessment of the clinical symptoms (CCS and NYHA) of the patients
Time frame: 3, 6 and 12 month
The safety of the bone marrow-derived stem cells delivery modes, expressed as the rates of long-term major adverse cardiac events (MACE: death, target vessel revascularization and non-fatal AMI)
Time frame: 3, 6 and 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irene Lang, MD study director
Department of Cardiology, Medical University of Vienna
Dietmar Glogar, MD study chair
Department of Cardiology, Medical University of Vienna
Mariann Gyongyosi, MD principal investigator
Department of Cardiology, Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bone marrow-derived stem cells implantation in people with Myocardial Infarction, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in resting myocardial perfusion defect size by gated SPECT scintigraphy 3-6 months after the percutaneous intracoronary or combined bone marrow-derived stem cells therapy. (time frame: 3-6 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2010.